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Daily Dose: ONTY, FOLD Crumble, OGXI Sails PACIFIC, VRTX Hep C Boxed, IDRA Soars

Daily Dose: ONTY, FOLD Crumble, OGXI Sails PACIFIC, VRTX Hep C Boxed, IDRA Soars
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Shares of Oncothyreon Inc. (ONTY: Quote) plunged over 51 percent on Wednesday after the company announced that its investigational lung cancer drug - L-BLP25, formerly referred to as Stimuvax, failed in a phase III trial.

In the phase III trial, known as START, L-BLP25 did not meet its primary endpoint of an improvement in overall survival in patients with non-small cell lung cancer. The trial was conducted by Merck Serono, a division of Merck KGaA of Darmstadt, Germany, under a license agreement with Oncothyreon.

Shares of Amicus Therapeutics Inc. (FOLD: Quote) fell more than 50% in after-hours trading on Wednesday following the failure of its investigational drug - Migalastat HCL, in a phase III fabry monotherapy study.

Migalastat HCL, also known as Amigal, is being evaluated in 2 phase III studies - dubbed Study 011 and Study 012, as a monotherapy for Fabry disease.

In the Study 011, the results of which were announced today, there was no statistical significance in pre-specified primary endpoint between the treatment group and placebo group.

The results from the second phase III trial - Study 012, are scheduled to be reported in 2014.

Amicus has a strategic collaboration with GlaxoSmithKline plc (GSK) for the development of Migalastat HCL.

A suit filed by Endo Health Solutions Inc.'s (ENDP: Quote) subsidiary, Endo Pharmaceuticals, against the FDA related to its original formulation of OPANA ER has been dismissed by the U.S. District Court for the District of Columbia.

OPANA ER is indicated for the relief of moderate to severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time. The original formulation was withdrawn and a reformulated version designed to be crush-resistant was launched by Endo in March 2012.

In its complaint filed last month, Endo Pharma had alleged that the FDA failed to meet its legal obligation to determine in a timely manner as to whether the original formulation of Opana ER was withdrawn for reasons of safety.

Two companies - Impax and Actavis have already received FDA approval for generic versions of the original formulation of OPANA ER. The ruling by the court now allows for a generic non-tamper resistant version to enter the market on Jan. 2, 2013.

Meanwhile, the FDA intends to make its determination by May 2013.

OncoGenex Pharmaceuticals Inc. (OGXI: Quote) has initiated a phase II study evaluating OGX-427 in men with metastatic castrate-resistant prostate cancer. The study, dubbed PACIFIC, aims to determine if adding OGX-427 to Johnson & Johnson's prostate cancer drug Zytiga can reverse or delay treatment resistance.

The study will be conducted at approximately 15 sites in the U.S. and Canada and is being managed by the Hoosier Oncology Group.

MethylGene Inc. (MYG.TO: Quote) has completed enrollment in a phase II trial evaluating its novel antifungal agent - MGCD290 for moderate-to-severe vulvovaginal candidiasis.

In the trial, which has enrolled over 200 patients, MGCD290 plus fluconazole is compared with fluconazole alone. Topline data from this trial are expected in March of 2013.

Vertex Pharmaceuticals Inc. (VRTX: Quote) has announced that its hepatitis C drug Incivek will sport a Boxed Warning on its label warning about the fatal and non-fatal serious skin reactions associated with the drug's use.

Incivek was approved by the FDA in May 2011 and by Health Canada in August 2011 for use in combination with pegylated-interferon and ribavirin for adults with genotype 1 chronic hepatitis C with compensated liver disease, including cirrhosis.

Cempra Inc. (CEMP: Quote) has initiated a global phase III trial to evaluate its fluoroketolide antibiotic candidate - oral Solithromycin, in patients with community-acquired bacterial pneumonia.

The trial is designed to enroll 800 patients who will be randomized to receive either oral Solithromycin, an 800 mg loading dose followed by 400 mg once daily for a total of five days, or once-daily oral administration of 400 mg of Moxifloxicin for seven days. The primary endpoint will be non-inferiority of early response at 72 hours, which is specified by the proposed FDA guidance.

The trial is expected to be completed in the first half of 2014.

ADVENTRX Pharmaceuticals Inc. (ANX: Quote) announced that its investigational drug ANX-188 for use in the phase III study, manufactured using its proprietary purification process, has passed quality control release specifications at its contract manufacturer.

The phase III study, dubbed EPIC, designed to evaluate whether ANX-188 can reduce the duration of vaso-occlusive crisis (VOC) in subjects with sickle cell disease, is expected to be initiated as early as next month.

Shares of Idera Pharmaceuticals Inc. (IDRA: Quote) rose as much as 49 percent in intraday trading on Wednesday before closing 19 percent higher at $0.92, following positive results from the company's psoriasis study.

In the phase II trial, which evaluated Idera's investigational drug - IMO-3100, in patients with moderate-to-severe plaque psoriasis, IMO-3100 demonstrated significant improvements in Psoriasis Area Severity Index scores after four weeks of treatment.

The company plans to present complete clinical data from the trial at an upcoming medical meeting.

ImmunoGen Inc. (IMGN: Quote), announced that Amgen Inc. (AMGN) has licensed the exclusive right to use its maytansinoid TAP technology to develop anticancer therapeutics to a third target, which is undisclosed.

Amgen licensed rights for two other targets in 2009 and has two compounds in clinical testing under those licenses.

For each license, ImmunoGen receives a $1 million upfront payment and is entitled to receive milestone payments potentially totaling $34 million plus royalties on the sales of any resulting products.

ImmunoGen's TAP, Targeted Antibody Payload technology strives to maximize the efficacy of antibody drugs against cancer cells.

Sanofi-Aventis, Genentech - owned by Swiss pharmaceutical giant Roche, Bayer Healthcare, Biogen Idec Inc., Novartis AG and Biotest AG are ImmunoGen's other collaborative partners that use its TAP technology.

Shares of Hemispherx Biopharma Inc. (HEB) have lost 46 percent in the past five days ahead of the FDA panel review of its experimental chronic fatigue syndrome drug, Ampligen.

The NDA for Ampligen is all set to be reviewed by FDA advisory panel tomorrow - December 20, 2012.

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by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

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